Albumin in Acute Stroke (ALIAS) Trial-Part 2: A Phase III Randomized Multicenter Clinical Trial of High-Dose Human Albumin Therapy for Neuroprotection in Acute Ischemic Stroke

INTERVENTION: Trade Name: Buminate 25% Product Name: Buminate 25% Pharmaceutical Form: Solution for infusion Pharmaceutical form of the placebo: Solution for injection Route of administration of the placebo: Intravenous use CONDITION: Acute Ischemic Stroke Therapeutic area: Diseases [C] ‐ Cardiovascular Diseases [C14] PRIMARY OUTCOME: Main Objective: To ascertain whether high‐dose human albumin (ALB) therapy confers neuroprotection in acute ischemic stroke over and above best standard of care. (Specifically, to determine whether ALB therapy increases the proportion of acute ischemic stroke patients with favorable outcome compared to placebo therapy at 3 months from randomization, as measured by the NIHSS and mRS.) Primary end point(s): The primary outcome is the favorable outcome, defined as either NIH Stroke Scale (NIHSS) score of 0 or 1, or a modified Rankin Score (mRS) of 0 or 1, or both, measured at 3 months from randomization. Secondary Objective: To evaluate: ‐ overall clinical outcome (as assessed by the global statistical test of NIHSS, mRS, and BI scores) at 3 months post‐randomization, ‐ overall clinical outcome as assessed by the full scale of the modified Rankin scale, ‐ neurological outcome as assessed by NIHSS score at 3 months post‐randomization, ‐ functional outcome as assessed by mRS and BI at 3 months post‐randomization, ‐ quality‐of‐life as assessed by EuroQol at 3 months and 1 year post‐randomization, and by SSQOL instruments at 3 months post‐randomization, ‐ robustness of ALB therapy as measured by a favorable outcome of mRS of 0 or 1at one year post‐randomization, ‐ incidence of recurrent ischemic stroke within 1 month, 3 months and 1 year post‐randomization, as assessed by QVSFS, ‐ mortality within 3 months and 1 year post‐randomization, ‐ incidence of symptomatic ICH within 24 (± 6) hours of randomization, ‐ cognition measured at 3 months by Trailmaking A and B.; Timepoint(s) of evaluation of this end point: 3 months from randomization SECONDARY OUTCOME: Secondary end point(s): Secondatory end points are measured, as specified, out to 12 months from randomization. INCLUSION CRITERIA: ‐ Acute ischemic stroke ‐ Age 18 years through 83 years (have not had their 84th birthday). ‐ NIHSS score of 6 or greater as assessed immediately prior to intravenous thrombolysis treatment if the patient is eligible for intravenous thrombolysis or immediately prior to randomization for patients not eligible for intravenous thrombolysis. ‐ Initiation of ALB/placebo within 5 hours of stroke onset, and within 90 minutes of the start of thrombolysis with intravenous (IV) tPA if that therapy is used. Signed and dated informed consent has been obtained. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18‐64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range